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510(k) Data Aggregation

    K Number
    K250268
    Device Name
    HyperSnap Surgical System (HSS)
    Manufacturer
    Hypervision Surgical
    Date Cleared
    2025-06-24

    (145 days)

    Product Code
    FET, FET, MUD
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hypervision Surgical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HyperSnap Surgical System is a real-time video camera system utilising computational hyperspectral imaging in the visible spectrum. The system is intended to be used intraoperatively to relay a standard RGB video feed used for visualisation alongside corresponding tissue oxygenation information presented as a corresponding two-dimensional real-time video feed. The system is intended for use as an adjunctive monitor of the haemoglobin oxygen saturation of blood (StO2) in the superficial tissue in the surgical field of view. The HyperSnap Surgical System may help identify patients at risk of tissue ischaemia. The system is indicated for use in all populations for open and minimally invasive general surgical applications utilising compatible surgical telescopes (exoscopes and rigid endoscopes). The prospective clinical value of measurements made with StO2 has not been demonstrated in disease states.
    Device Description
    Hyperspectral imaging (HSI) is an optical imaging modality that carries information about tissue properties, facilitating objective tissue characterisation without the need for any exogenous contrast agent. HSI is non-invasive, non-contact, and does not make use of ionising radiation. The HSS is an HSI system that seamlessly integrates into surgical workflows to provide critical, but currently unavailable, tissue property information during surgery. The HSS provides for visualisation of real-time tissue oxygenation saturation (StO2) information alongside conventional red-green-blue (RGB) visualisation. Additionally, the mean StO2 value within a user-defined ROI is reported. Imaging is displayed at video rate ensuring instant surgeon feedback and intra-operative tissue assessment to facilitate surgical guidance and decision making. The HSS is an artificial intelligence (AI) / machine learning (ML) enabled device. Training data for the deep learning algorithm comprises high resolution medical imaging datasets which collectively offer representative spatial and spectral variation across the intended target tissues and surfaces. The core components of the HSS include, amongst others, a hyperspectral camera, the HyperSnap Camera, a computational workstation, the Camera Control Unit (CCU), the Camera Electrical Isolator and Camera Electrical Isolator Power Supply. The HyperSnap Camera is a lightweight surgical camera with a snapshot hyperspectral imaging sensor. Our surgical imaging technology exploits highly optimised algorithms and software to leverage snapshot HSI hardware for the extraction of advanced optical properties of observed tissues. The camera can be securely mounted but is easily manoeuvrable, allowing for controlled mobilisation and immobilisation of the imaging system by a single operator without the need for an assistant. The CCU runs the HyperSnap Software which implements a deep learning approach for super-resolution and reconstruction of acquired snapshot hyperspectral images.
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